EP2714126B1 - Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung - Google Patents

Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung Download PDF

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Publication number
EP2714126B1
EP2714126B1 EP12724292.3A EP12724292A EP2714126B1 EP 2714126 B1 EP2714126 B1 EP 2714126B1 EP 12724292 A EP12724292 A EP 12724292A EP 2714126 B1 EP2714126 B1 EP 2714126B1
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EP
European Patent Office
Prior art keywords
partial circuit
treatment device
membrane filter
blood treatment
membrane
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP12724292.3A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2714126A1 (de
Inventor
Sören GRONAU
Joachim Noack
Jürgen HAECKER
Ralf MÜLLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
Original Assignee
Fresenius Medical Care Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Priority to EP18172705.8A priority Critical patent/EP3388094B1/de
Publication of EP2714126A1 publication Critical patent/EP2714126A1/de
Application granted granted Critical
Publication of EP2714126B1 publication Critical patent/EP2714126B1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3643—Priming, rinsing before or after use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3643—Priming, rinsing before or after use
    • A61M1/3644—Mode of operation
    • A61M1/365—Mode of operation through membranes, e.g. by inverted trans-membrane pressure [TMP]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus

Definitions

  • the present invention relates to a method for rinsing and / or filling a blood treatment apparatus and a blood treatment apparatus.
  • the dialysis cycle, the extracorporeal blood circulation as well as the dialysis cycle, which is semipermeably separated from the circulatory system, are usually rinsed.
  • the blood in the hollow fibers of the dialyzer flows in the opposite direction to the flow direction of the dialysis solution.
  • the dialysis solution is located outside the hollow fibers of the dialyzer.
  • the dialyzers are arranged so that the blood flows during the treatment from bottom to top through the dialyzer, while the dialysis solution flows from top to bottom. For this reason, the dialysate-side air removal, especially in large dialyzers, often not optimal and it remains regularly, even recognizable to the user, residual air accumulations in the dialyzer, especially on the dialysate back.
  • WO 2004/43520 A1 a method is described in which first the fibers of the filter are filled by means of the blood pump from the inside at a low pressure or flow and then rinsed with a higher pressure. Then the dialysate z. B. pressed through the membrane into the dialysate. There it is then pumped around by the dialysate pump for rinsing, and in part, a reversal of direction is possible. By flushing at higher rivers, the air should be removed.
  • the filling of the hemodialyzer is initially on the blood side with the blood pump. The priming solution is transported by the blood pump into the interior of the hollow fibers and from there pushed through the membrane to the dialysate side.
  • a method for rinsing and / or filling a blood treatment device having the features of claim 1. Thereafter, it is provided that in a method for rinsing and / or filling a blood treatment device, wherein the blood treatment device at least one membrane filter, at least a first partial circuit and at least one second partial circuit, wherein the first and the second partial circuit are separated by the membrane filter semipermeable and wherein the first partial circuit is the dialysis circuit and the second partial circuit is the extracorporeal blood circulation, at least so moved that the second partial circuit for Atmosphere is at least temporarily open and being air is displaced from the first to the second partial circuit via the membrane of the membrane filter.
  • the first partial cycle is filled first, while the second partial cycle is still empty.
  • the second partial circuit is open to the atmosphere at least temporarily, because this is achieved in particular that in the second partial circuit only a small back pressure prevails when air from the first partial circuit is to be displaced in the second partial circuit, as during air over the membrane the membrane filter is displaced from the first to the second partial circuit is provided.
  • the air can be easily removed via the membrane.
  • the rinsing and / or filling of the blood treatment device is the priming of a blood treatment device.
  • the membrane filter is preferably a hollow fiber membrane filter.
  • This blood treatment device may advantageously be a dialysis machine.
  • the fluid used for the filling process or for the priming can be, for example, the dialysis fluid.
  • the air removal from the membrane filter can be significantly improved without mechanical manipulation of the membrane filter and without technical changes to the blood treatment device.
  • the volume flow does not exceed a predetermined threshold, wherein at this threshold still no complete wetting and / or impregnation of the membrane by the fluid is present.
  • the membrane filter is preferably and in particular in working or treatment position in the or on the blood treatment device arranged substantially vertically.
  • the first and second subcircuits are arranged such that the directions of flow through the membrane filter are in opposite directions, i. H. that the membrane filter is flowed through in accordance with the countercurrent principle.
  • the fluid flows during the filling process in the first partial circuit from top to bottom on the corresponding side of the membrane filter through the membrane filter and in the second partial circuit accordingly reversed, ie from bottom to top on the corresponding side of the membrane filter through the membrane filter.
  • the formation of air bubbles in the first partial cycle is advantageously reduced by promoting the removal of the air via the membrane.
  • air is transferred through the membrane into the second partial circuit and from there z. B. displaced into the environment.
  • the waiver of the application of a negative pressure in the first partial circuit causes the hollow fiber membrane can remain longer permeable to air during the filling process and no air can flow backwards from the second partial circuit in the first partial circuit, which would mean that the air is no longer could be removed.
  • the first partial circuit is the dialysis circuit and that the second partial circuit is the extracorporeal blood circuit.
  • the membrane filter is first filled in a balancing manner on the side of the first partial circuit, wherein in the balancing filling equal volumes are conveyed to and from the membrane filter and wherein a balancing chamber is used for the balancing filling.
  • balance chamber switching it is also possible that during the filling of the membrane filter on the side of the first partial circuit one or more balance chamber switching done. It is particularly advantageous if preferably three balance chamber switchings are provided.
  • the membrane filter is filled on the side of the first partial circuit with a first volume flow which does not exceed about 500 ml / min.
  • the blood treatment device has a secondary air separator, in which the air is conveyed out of the membrane filter during the filling of the membrane filter on the side of the first partial circuit.
  • air is displaced from the secondary air separator and from the first partial circuit via the semi-permeable membrane of the membrane filter in the second partial circuit.
  • a charge pump of the blood treatment device can be used.
  • the present invention relates to a blood treatment device having the features of claim 8. Thereafter, it is provided that the blood treatment device with at least one membrane filter, with at least one first partial circuit and with at least one second partial circuit, with at least one first pumping means for conveying a fluid in the first partial circuit and at least one second pumping means for conveying a fluid in the second partial circuit, the first and the second partial circuit through the membrane filter are semipermeable separated, wherein the blood treatment device comprises at least one control and / or regulating means, so that the blood treatment device is at least operable so that by means of separate pumping means indirectly and / or directly at least the first and the second partial circuit and the membrane filter can be flushed and / or filled so that the second partial circuit is open at least temporarily to the atmosphere and air is displaced via the membrane of the membrane filter from the first to the second partial circuit.
  • the blood treatment device is designed such that during filling no negative pressure is applied to the first partial circuit.
  • the first partial circuit with a uniform and / or a pulsatile volume flow can be filled with a fluid, wherein the volume flow does not exceed a predetermined threshold, wherein at this threshold value is not complete wetting and / or impregnation of the membrane by the fluid, and / or where
  • the blood treatment device is a dialysis machine and / or that the membrane filter is a hollow fiber membrane filter, in particular a dialyzer, and / or that the first partial circuit is the dialysis circuit and / or that the second partial circuit is the extracorporeal blood circulation.
  • venting means by means of which the second subcircuit can be vented to the environment and / or atmosphere and / or by means of which the second subcircuit can be opened to the environment and / or atmosphere, a clamping element and / or an element comprising a hydrophobic membrane and / or a valve is and / or comprises, wherein preferably the valve is a vent valve and / or a valve that is such that it increases the compliance of a disposable tubing set of the blood treatment device, in particular a single-neeedle valve.
  • the clamp member may be, for example, a hose portion of the disposable provided with a manual clamp, whereby the disposable can be opened and closed to the atmosphere.
  • the blood treatment device has at least one balance chamber, by means of which indirectly and / or directly the first partial circuit can be filled in a balancing manner.
  • the blood treatment device is designed and arranged such that the membrane filter is initially filled on the side of the first partial circuit balancing, with the balancing filling equal volumes are conveyed to and from the membrane filter by means of the first pumping means and by means of the balance chamber ,
  • the membrane filter is filled on the side of the first partial circuit by means of the first pumping means with a volume flow which does not exceed about 500 ml / min.
  • the blood treatment device has a secondary air separator into which the air from the membrane filter can be conveyed during the filling of the membrane filter on the side of the first partial circuit.
  • the filling method according to the invention is preferably carried out with a blood treatment machine according to the invention, which is a dialysis machine or a dialysis monitor, wherein the first partial circuit is the dialysate circuit and the second partial circuit is the extracorporeal blood circulation.
  • the membrane for air well remains permeable. Because by reducing the wetting and reducing impregnation of the membrane of the membrane filter is achieved that the air can pass through the membrane relatively unhindered. However, such unhindered passage of air is no longer readily possible if the membrane of the membrane filter is heavily wetted with fluid and / or impregnated.
  • the dialyzer is connected before the start of the process at least on the hydraulic side, as already standard.
  • the blood-side connection is not necessary for carrying out the method according to the invention, but it is provided that the blood side is open to the atmosphere. This will in particular prevents the dialysate-side filling from deteriorating, since a pressure increase takes place in a filter which is closed on the blood side due to the air passing on the blood side, which counteracts a further venting of the dialysate side.
  • the extracorporeal blood circulation is opened to the environment. This can for example take place in that a vent valve, which in the venous part of the extracorporeal blood circulation z. B. is provided in the area or on a drip chamber or air trap is opened.
  • a clamping element and an element comprising a hydrophobic membrane is provided as a venting means.
  • the clamp member may be, for example, a hose portion of the disposable provided with a manual clamp, whereby the disposable can be opened and closed to the atmosphere.
  • a valve may be provided as a vent valve and / or a valve that is such that it increases the compliance of a disposable tubing set of the blood treatment device, such.
  • B. a SingleNeedle valve It is conceivable in this context, in particular, to open the SingleNeedle valve, if it is a blood treatment device for performing a SingleNeedle method and a corresponding valve is provided.
  • the dialyzer is already connected to the hose system during filling.
  • This hose system is also not open to the environment, because after inserting the two hose clamps are closed and the valve for venting the venous chamber is also closed in the ground state.
  • the dialyzer is initially filled on the hydraulic side, ie on the side of the first partial circuit.
  • the filling routine has been modified so that the first five balance chamber switchings of the balance chamber are performed via the dialyzer with reduced and uniform dialysate flow. This is 500 ml / min.
  • the air from the dialyzer is thereby conveyed into the secondary air separator.
  • venting via the membrane can only take place if capillary parts have not yet come into contact with dialysate. If all capillaries are wet at the end of the filling routine, air can no longer pass through the capillary membrane and the residual air must be flushed out of the dialyzer. In order to prevent that even at an early stage of the filling routine all capillaries are drenched or soaked, the filling volume flow must preferably have a uniform course.
  • the air which has passed into the secondary air separator is detected there and is normally separated by applying a negative pressure to extract the air.
  • This process is also referred to as secondary air separation.
  • the secondary air separation is prevented because the application of a negative pressure in the balancing circuit leads to an undesired passage of air from the blood to the dialysate side. This can be detected, for example, by abrupt pressure drops at the venous pressure sensor at the end of the balance chamber switchover.
  • the balancing system is opened at an additional valve.
  • the balancing chamber conveys additional liquid into the balancing circuit in the filling program.
  • the driving force here is the charge pump, which delivers a flow of about 1,300 ml / min.
  • the dialyzer membrane After a few switches, the dialyzer membrane is completely wetted or saturated and there is no further air passage on the blood side more. The remaining air is displaced by further Greumscen until liquid can be detected again.
  • the dialyzer filling ends. Of course, with smaller filters, the filling can of course also be terminated sooner. From the sixth balance chamber switchover, the normal flow is filled with the maximum flow available from the device (1000ml / min), because of the high flow rate Peak flow during Grepscen the capillaries are then wetted over a large area anyway.
  • an evaluation of balance chamber switching in the filling program is used to provide information about the dialysate Tooen filling volume of the filter. Together with the information of the blood-side filling volume (can be determined when filling the blood side) can optionally be determined on the machine side of the dialyzer. Furthermore, an evaluation of the venous (and prefilter) pressure pulses allows to detect whether the blood tubes have been connected to the dialyzer, without leakage of liquid.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)
EP12724292.3A 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung Active EP2714126B1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP18172705.8A EP3388094B1 (de) 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161457740P 2011-05-24 2011-05-24
DE102011102492A DE102011102492A1 (de) 2011-05-24 2011-05-24 Verfahren zum Spülen und/oder zum Befüllen einer Blutbehandlungsvorrichtung sowie Blutbehandlungsvorrichtung
PCT/EP2012/002174 WO2012159740A1 (de) 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung

Related Child Applications (2)

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EP18172705.8A Division-Into EP3388094B1 (de) 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung
EP18172705.8A Division EP3388094B1 (de) 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung

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EP2714126A1 EP2714126A1 (de) 2014-04-09
EP2714126B1 true EP2714126B1 (de) 2018-07-18

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EP12724292.3A Active EP2714126B1 (de) 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung
EP18172705.8A Active EP3388094B1 (de) 2011-05-24 2012-05-22 Verfahren zum spülen und/oder zum befüllen einer blutbehandlungsvorrichtung sowie blutbehandlungsvorrichtung

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Country Status (8)

Country Link
US (1) US9950104B2 (ja)
EP (2) EP2714126B1 (ja)
JP (1) JP6204909B2 (ja)
CN (2) CN103635211B (ja)
DE (1) DE102011102492A1 (ja)
ES (1) ES2691474T3 (ja)
TR (1) TR201815280T4 (ja)
WO (1) WO2012159740A1 (ja)

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CN103635211B (zh) 2018-01-02
CN107929841A (zh) 2018-04-20
JP2014521387A (ja) 2014-08-28
EP2714126A1 (de) 2014-04-09
JP6204909B2 (ja) 2017-09-27
TR201815280T4 (tr) 2018-11-21
EP3388094B1 (de) 2021-03-10
US9950104B2 (en) 2018-04-24
DE102011102492A1 (de) 2012-11-29
WO2012159740A1 (de) 2012-11-29
ES2691474T3 (es) 2018-11-27
CN103635211A (zh) 2014-03-12
US20120298580A1 (en) 2012-11-29
CN107929841B (zh) 2021-06-18
EP3388094A1 (de) 2018-10-17

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